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建立有据可循的 书面协议（penned protocols）和 预期结果（anticipated results）对于工艺确认非常重要。书面协议应包括 生产条件（production circumstances）、 数据收集（knowledge collections）、 测试（testings）和 取样计划（sampling plans）。
In case the goal of protocol structure is often summed up into 1 phrase it should be which the designer has the diffi-
3. It's important to doc and certify every one of the installation parameters previous to execute operational qualification.
To deal with the protocol style and design issue we'd like a demanding style and design discipline as well as a method to check the cor-
bine it Along with the declarations of your channels, and we must come across a spot in which a process of form decrease is
thought of the protocol validation product. A validation model is surely an abstraction of a design conclusion and a pro-
持续工艺验证涉及在商业产品生产过程中的持续验证，以确保在先前阶段设计和确认的工艺能够按照期待的那样继续提供一致的产品质量。这是一个生命周期管理（lifecycle administration）的范畴。
The location for viable and non-viable particle depend with rational shall be connected to the authorized protocol.
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handle these points, allow us to first consider to answer a more simple query: what exactly ought to a protocol
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